"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su,Cavanaugh Heart Center, Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA

AF Symposium 2015

Sébastien Knecht PMD PhD

AFACART Clinical Trial: Preliminary Results of the CardioInsight—ECVUE System in Multiple Centers

Introduction

In preparation for their ablation the patient dons the ECGI vest-like device. The data generated creates an image of the heart and pinpoints sites (“drivers”) producing A-Fib signals. This 3-D computer model of the patient’s heart is used during the ablation procedure.

AFACART Clinical Trial Design and Participants

The AFACART trial is a European multicenter, feasibility, non-randomized study using “Panoramic Electrographic Non-Invasive Mapping”, specifically the CardioInsight—ECVUE System, for ablation of persistent A-Fib.

AFACART stands for “Non-Invasive Mapping of Atrial Fibrillation,” a new name for ECGI

Ablation patients are to be followed for 12 months. The effectiveness of Panoramic Electrographic Non-Invasive Mapping is to be compared to conventional mapping and ablation procedures.

Eight European centers in France, Belgium and Germany are participating in this clinical trial. None of these centers had any practical experience with this system before this study.

Ablation Steps One to Three

In an important change to standard ablation procedures, the first step in the ECGI/ECVUE ablation process is ablation of A-Fib drivers (rotors and foci). (This is in comparison to the step-wise approach that begins with ablation of the pulmonary vein openings.)

In 94% of patients, driver ablation had a significant impact on the A-Fib termination process. A-Fib cycle length was prolonged in all persistent patients except for 6%. Even patients who were not terminated (27%) had their A-Fib cycle length prolonged by driver ablation.

After 12 months, 72% of patients were A-Fib free and no longer taking antiarrhythmic meds (AADs). 31% had Atrial Tachycardia recurrence, but many had a second ablation.

Overall 83% were A-Fib free, 17% had Atrial Tachycardias and only 9% were still in A-Fib.

Ablation procedure time averaged only 44.7 minutes. As the number of driver regions increased, the ablation success rate decreased. 66% of drivers were in the Left Atrium, 34% in the right. 70% of termination sites were in the left atrium, 30% in the right.

Driver Sites and CFAEs

• In these persistent A-Fib patients, 50% of both atria had CFAEs.
• Most (but not all) driver sites contained CFAEs.
• Successful driver ablation only ablated 19% of both atria (this is a major improvement and resulted in much less ablation damage to the heart compared to trying to ablate all CFAE areas).

Dr. Knecht stated that “use of the ECVUE system seems to result in a more specific selection of CFAEs leading to a more targeted ablation strategy.”

Dr. Knecht’s Conclusions

Ablation of A-Fib drivers is associated with a high rate of A-Fib termination.

• Drivers are distributed in both atria (2/3 LA and 1/3 RA).
• Results are reproducible among centers without prior practical experience with the system.
• Preliminary chronic results are very promising.

Editor’s Comments:

Driver Ablation More Important Than PVI in Persistent A-Fib: ECGI is changing the way ablations are done and our understanding of A-Fib. In persistent A-Fib, the mapping and ablation of drivers is more important and is done before a PVI ablation. While driver ablation had a 64% success rate, doing a standard PVI after driver ablation only improved results by 2%.

ECGI/ECVUE Major Improvement in Ablation Success Rate: An 83% success rate after 12 months following ablations for tachycardias, is a major improvement and source of hope for persistent A-Fib patients. These results were even better when one considers that only 9% were still in A-Fib.

ECGI/ECVUE Results in Much Fewer Ablation Burns: Previous protocols for ablating persistent A-Fib usually involved mapping and ablating CFAEs. But CFAEs in persistent A-Fib patients can cover 50% of the atria surfaces which often necessitated a lot of burns and debulking.

Too many ablation burns could result in the development of fibrosis (dead heart tissue where the ablation catheter produced burns and scarring) and a stiffening of the atria with loss of pumping ability. ECGI/ECVUE only requires ablating 19% of the CFAE areas resulting in much less lasting damage to heart tissue.

Driver Ablation Prolongs A-Fib Cycle Length: Driver ablation had a major effect on the A-Fib termination process. A-Fib cycle length was prolonged in all but 6% of the persistent A-Fib patients. This is perhaps a first step in improving outcomes for persistent A-Fib patients.

Reproducibility: The most important finding of Dr. Knecht’s report is that ECGI/ECVUE works in other centers without doctors (operators) having to undergo extensive training.

These preliminary results from this multi-center clinical trial are quite impressive for the treatment of patients with persistent A-Fib. Hopefully it won’t be long before the ECGI/ECVUE system is available in more countries. (ECGI was invented at Washington Un. in St. Louis, MO and is available there on a limited basis.)

Disclaimer: the authors of this Web site are not medical doctors and are not affiliated with any medical school or organization. The information on this site is not intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health professional prior to starting any new treatment or with any questions you may have regarding a medical condition. Nothing contained in this service is intended to be for medical diagnosis or treatment.